Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
25 maj 2017 uppdaterad av: Wake Forest University Health Sciences
Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
OBJECTIVES:
Primary
- To determine the ability to administer 8 continuous weeks of therapy within the first 3 months of enrollment with paricalcitol when given together with taxane or ixabepilone therapy in women with metastatic breast cancer.
- To estimate the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose.
Secondary
- To determine a dose of paricalcitol that can be taken continuously that maintains a normal calcium level when combined with a taxane or ixabepilone.
- To determine if baseline levels of 25-hydroxycholecalciferol and parathyroid hormone (PTH) are associated with time to treatment failure in these patients.
- To determine if PTH levels decline from baseline in patients treated with paricalcitol in combination with taxane or ixabepilone therapy.
OUTLINE: Beginning on day 1, patients receive oral paricalcitol. The dose of paricalcitol is increased every 2 weeks until the serum calcium level is between 9 mg/dL and 11.4 mg/dL. Once this level is reached, the patient continues at that dose for the duration of the study. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation, docetaxel, or paclitaxel once a week or once every 3 weeks or ixabepilone once every 3 weeks. Treatment continues for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 120 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria
Histologically confirmed invasive breast cancer
- Metastatic or recurrent disease
- Patients with bone metastasis only are eligible and evaluable for time to progression
- Candidate for taxane or ixabepilone therapy
- At least one lesion that can be measured in at least one diameter ≥ 2 cm by CT scan
- No symptomatic brain metastases or other symptomatic CNS metastases
- ECOG performance status 0 or 1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0 g/dL
- Albumin corrected serum calcium < 10.5 mg/dL
- Fertile patients must use effective contraception during and for at least 1 year after study participation
- At least 2 weeks since prior chemotherapy or radiation therapy
- Prior and concurrent taxane or ixabepilone therapy allowed
- Concurrent oral multivitamins allowed (i.e., Centrum or One a Day)
- Concurrent bisphosphonates allowed
Exclusion Criteria
- History of allergy to calcitriol, paricalcitol, or other Vitamin D compounds
- History of drug or alcohol abuse within the past 6 months
- History of other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or other cancer if the patient has been disease-free for 5 or more years
- Serious medical illness that would limit survival to < 3 months
- Active, uncontrolled bacterial, viral or fungal infection
- Poorly controlled diabetes
- Concurrent supplemental calcium
- Concurrent digitalis compounds
- Concurrent chemotherapy
- Concurrent biologic therapy, including trastuzumab and bevacizumab
- Concurrent hormonal agents for breast cancer except luteinizing hormone-releasing hormone agonists
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Paricalcitol (Zemplar)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical feasibility of therapy administration
Tidsram: Baseline to 8 weeks
|
To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
|
Baseline to 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone
Tidsram: Baseline to 8 weeks
|
Baseline to 8 weeks
|
|
|
Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure
Tidsram: Baseline to 8 weeks
|
To determine if baseline levels of 25(OH)D and parathyroid hormone are associated with time to treatment failure in patients treated with the combination of paricalcitol and a taxane or ixabepilone
|
Baseline to 8 weeks
|
|
Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure
Tidsram: Baseline to 8 weeks
|
To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone
|
Baseline to 8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Julia A. Lawrence, Wake Forest University Health Sciences
- Huvudutredare: Susan A. Melin, MD, Wake Forest University Health Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2008
Primärt slutförande (Faktisk)
1 november 2011
Avslutad studie (Faktisk)
1 mars 2013
Studieregistreringsdatum
Först inskickad
17 mars 2008
Först inskickad som uppfyllde QC-kriterierna
17 mars 2008
Första postat (Uppskatta)
18 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 maj 2017
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000583652
- P30CA012197 (U.S.S. NIH-anslag/kontrakt)
- CCCWFU-74307 (Annan identifierare: Comprehensive Cancer Center of WFUHS)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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